Status:
COMPLETED
IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Fakultas Kedokteran Universitas Indonesia
Dr Cipto Mangunkusumo General Hospital
Conditions:
Glaucoma Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Glaucoma is a group of diseases that damage the eye's optic nerve, result in progressive visual field defect and blindness. The aim of glaucoma management is to reduce IOP, and glaucoma implant surger...
Detailed Description
The study is to measure the efficacy of new GDD that made with polymethyl methacrylate. The primary outcome is IOP reduction. The secondary outcome is glaucoma medication post surgery and complication...
Eligibility Criteria
Inclusion
- End stage glaucoma patients whose IOP is failed to be controlled by glaucoma medications
- Patients that are willing to participate in the study
- Patients with \<6/60 visual acuity
- Patients above 18 years
Exclusion
- Patients with combination surgery indication (eg. glaucoma with cataracts)
- Eyes with congenital disease of anterior segment dysgenesis
- Eyes with uneven surface of the cornea that the measurement IOP with Goldmann tonometer could be difficult
- Eyes with broad conjungtival cicatrix that are impossible to be implanted
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04052165
Start Date
July 1 2015
End Date
August 8 2020
Last Update
August 25 2021
Active Locations (1)
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1
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430